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AbbVie reports FDA has requested further information on subcutaneous pump used in its ABBV-951 combination therapy to treat Parkinson’s disease; treatment uses foscarbidopa and foslevodopa along with pump device
Published: March 23, 2023 by FiercePharma
FDA accepts BLA for Pfizer’s RSV maternal vaccine candidate for priority review; if approved it would be first vaccine for pregnant women to help protect against complications of RSV disease in infants from birth through six months
Published: February 21, 2023 by Pfizer Inc.
FDA grants Merck priority review of label expansions for Prevymis for prophylaxis of cytomegalovirus disease in adult kidney transplant patients; second sNDA to review extending Prevymis in adults receiving an allogeneic hematopoietic stem cell transplant
Published: February 17, 2023 by EquityBites
FDA to convene advisors to review experimental RSV vaccine candidate from Pfizer on February 28; group to meet in March to reviews RSV vaccine candidate from GSK
Published: February 03, 2023 by BioPharma Dive
Some FDA advisers upset that early data about new Moderna COVID-19 booster shot wasn't presented during approval review, citing lack of transparency in process; early, limited data suggested booster may not be more effective than original vaccination
Published: January 12, 2023 by Philadelphia Tribune

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